The present invention relates to a sterilisable dockable bag or container which has a sterilisable connector port and a method for attaching to a standard port of a sterile enclosure or isolation system. The ports when combined may be used to transfer sterilized items from the inside of the container to the sterile enclosure or isolation system. The present invention also relates to container combination which may be docked to a standard port of a sterile enclosure or isolation system.
U.S. Pat. No. 5,447,699 (Papciak) describes a combination container for holding sterilized elements and a sterilisable port. The container includes a flexible bag with a hole in it through which a collar with a flange is placed. The collar of the flange is heat sealed to the bag. The collar is sealed with a steam breathable tearable flap on its inside thus leaving a portion of the collar which is contaminated. To decontaminate this collar the port of the isolation system has piping for transferring a treatment fluid to the zone between the tearable flap and the outside of the port of the isolation system. This known bag and port suffers from the disadvantage that a sterilizing step is required after closure of the bag to the port of the isolation system.
U.S. Pat. No. 5,735,609 (Norton) describes a container for holding sterilized elements. In ""609 it is argued that the seal of the collar to the bag of ""699 is unsatisfactory. Instead, the container of ""609 includes a flexible bag having an opening which is attached to a connector port which is engageable with an isolation system. The open end of the bag is slid over the port and is clamped around the port. The open end of the bag is located in a sealing material which is fixed in a groove of the port. The sealing material may be a two-part epoxy. The front opening of the port is sealed by a door. The outer surface of this door is contaminated. The sealing arrangement of ""609 is an improvement over a simple design in which the open end of a flexible bag is simply clamped to a cylinder, but the sealing material requires careful location and its curing adds an extra complication to the manufacture of the container.
It is an object of the present invention to provide a sterilisable container combination with a connector port which allows easy manufacture of the container and to provide a relatively simple method for docking the connector port to the port of an isolation system.
It is a further object of the present invention to provide a sterilisable container combination and method of connecting it to an inlet port of an isolation system which avoids complex sealing arrangements or ones which may nave or develop inherent leaks.
It is still a farther object of the present invention to provide a sterilisable container combination and a method of connecting it to an inlet port of an isolation system which does not require an additional sterilization treatment when the container combination is docked to the port of an isolation system.
The present invention includes a sterilisable container combination comprising: a container having an opening; a hollow connector port having an internal bore, the container being sealingly secured to the connector port so that the opening in the container is in registry with the bore of the connector port; an adapter having an internal bore, the connector port and the adapter being sealably connectable by a damping and sealing device so that the internal bores of the connector port and the adapter are in open communication. Preferably the adapter has a removable door sealed to the end of the adapter remote from the sealable connection to the connector port.
The present invention also includes a plurality of sterilisable containers each having an opening and a hollow connector port having an internal bore, each container being sealingly secured to the connector port so that the opening in the container is in registry with the bore of the connector port; and a plurality of different adapters suitable for connecting to the inlet ports of different isolation systems, each adapter having an internal bore, the connector ports and the adapters being sealingly connectable by a common size of connecting and sealing devices so that the internal bores of the connector port and the adapter are in open communication.
The present invention provides a method of connecting a sterilized container to the inlet port of an isolation system, comprising the steps of: providing a container with a hollow connector port securely sealed to the container; sealingly connecting a first end of an adapter to the connector port of the container; and docking and sealing a second end of the adapter to the inlet port of the isolation system.
The present invention also includes a sterilisable container including a flexible bag, the flexible bag having a hole in a flat portion thereof and a hollow connector port fixed thereto, the connector port including a collar portion and a flange portion defining an internal bore of the connector port the inside surface of the flexible bag being sealed to an outside surface of the flange portion and the collar portion extending through the hole in the flexible bag.
The present invention also includes a method of producing a sterilisable container, comprising the steps of: providing a flexible sheet enclosure with a flat portion; providing a hole in the flat portion of the flexible sheet enclosure and fixing a hollow connector port thereto, the connector port including a collar portion and a flange portion defining an internal bore of the connector port, and sealing the inside surface of the flexible sheet enclosure to an outside surface of the flange portion, the collar portion extending through the hole in the flexible sheet enclosure. The enclosure may extend in one direction to form the container and the sheet material forms the walls of the container the flat portion being provided by a front face of the sheet enclosure perpendicular to the extension direction of the container and the hole is provided in the front face.
The present invention also includes a sterilisable container device comprising a first outer container and an inner flexible container, the outer container including a hollow connector port the connector port being sealed by a removable cover; and the removable cover including a holding device for the inner flexible container on the side of the cover facing towards the inner flexible container.
The dependent claims define further individual embodiments of the present invention. The present invention, its advantages and embodiments will now be described with reference to the following drawings.